{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T14:13:04Z","timestamp":1787062384487,"version":"build-2736575974"},"reference-count":26,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,7,17]],"date-time":"2025-07-17T00:00:00Z","timestamp":1752710400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Laryngoscope"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>This study evaluates complications associated with automated tympanostomy tube delivery systems (TDS) in pediatric patients through a systematic review and analysis of the Manufacturer and User Facility Device Experience (MAUDE) database.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Sources<\/jats:title>\n                    <jats:p>MEDLINE, Embase, Cochrane CENTRAL, Web of Science, and MAUDE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A systematic review following PRISMA guidelines identified studies on automated TDS, while the MAUDE database was queried using the product class \u201ctympanostomy tube delivery system with drug\u201d and relevant manufacturers. Primary outcomes included intra\u2010 and post\u2010procedural complications, while secondary outcomes assessed procedural success and escalation to general anesthesia (GA) or total intravenous anesthesia (TIVA) in the operating room (OR).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Intraprocedural complications occurred in 8.2% of cases. The most frequently cited complication in the literature was excessive movement or behavioral intolerance (56%), while inadequate anesthesia (38%) was the leading intraprocedural issue in MAUDE reports. The average procedural success rate was 91%, with 3.2% requiring OR escalation. Postprocedural complications occurred in 33% of cases, with tube occlusion (36%) and reluctance to undergo ear examinations (30%) as the most common short\u2010term events. Long\u2010term complications included otitis media with otorrhea (32%) and otitis media (25%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>While TDS were designed to streamline in\u2010office care, their effectiveness remains uncertain due to challenges in achieving adequate immobility and anesthesia in awake pediatric patients. Although complication rates appear comparable to traditional tympanostomy tubes, some reports highlight concerns regarding procedural distress. Further research is needed to refine patient selection, optimize anesthesia protocols, and assess long\u2010term outcomes to determine their role in pediatric otolaryngology.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Level of Evidence<\/jats:title>\n                    <jats:p>N\/A.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/lary.32434","type":"journal-article","created":{"date-parts":[[2025,7,17]],"date-time":"2025-07-17T12:05:16Z","timestamp":1752753916000},"page":"4936-4943","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Pediatric Complications of Automated Tympanostomy Tube Systems:\n                    <scp>MAUDE<\/scp>\n                    Analysis and Systematic Review"],"prefix":"10.1002","volume":"135","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-8505-1996","authenticated-orcid":false,"given":"Emily A.","family":"Clementi","sequence":"first","affiliation":[{"name":"Georgetown University School of Medicine  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5344-4455","authenticated-orcid":false,"given":"Seetha","family":"Aribindi","sequence":"additional","affiliation":[{"name":"Georgetown University School of Medicine  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr.","given":"Earl H.","family":"Harley","sequence":"additional","affiliation":[{"name":"Georgetown University School of Medicine  Washington DC USA"},{"name":"Department of Otolaryngology Head and Neck Surgery Georgetown University Hospital  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,7,17]]},"reference":[{"issue":"11","key":"e_1_2_7_2_1","first-page":"1","article-title":"Ambulatory Surgery in theUnited States, 2006","author":"Cullen K. A.","year":"2009","journal-title":"National Health Statistics Reports"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2011.546"},{"key":"e_1_2_7_4_1","unstructured":"Food and Drug Administration FDA Drug Safety Communication: FDA Approves Label Changes for Use of General Anesthetic and Sedation Drugs in Young Children 2017 https:\/\/www.fda.gov\/drugs\/drug\u2010safety\u2010and\u2010availability\/fda\u2010drug\u2010safety\u2010communication\u2010fda\u2010approves\u2010label\u2010changes\u2010use\u2010general\u2010anesthetic\u2010and\u2010sedation\u2010drugs."},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/0145561320924910"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/0194599815608366"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1177\/0194599816636100"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1177\/0194599816636101"},{"key":"e_1_2_7_9_1","unstructured":"Preceptis Medical Hummingbird TTS Tympanostomy Tube System accessed December 11 2024 https:\/\/www.hummingbirdeartubes.com."},{"key":"e_1_2_7_10_1","unstructured":"US Food and Drug Administration Tula System 2019 https:\/\/www.fda.gov\/news\u2010events\/press\u2010announcements\/fda\u2010approves\u2010system\u2010delivery\u2010ear\u2010tubes\u2010under\u2010local\u2010anesthesia\u2010treat\u2010ear\u2010infection."},{"key":"e_1_2_7_11_1","unstructured":"AventaMed Solo TTD: A New Standard of Care in Tympanostomy Tube Surgery accessed December 11 2024 https:\/\/aventamed.com\/."},{"key":"e_1_2_7_12_1","unstructured":"AAO\u2010HNS Foundation Position Statement: In\u2010Office Placement of Tubes in Pediatric Patients While Awake 2019 https:\/\/bulletin.entnet.org\/home\/article\/21247761\/aaohns\u2010position\u2010statement."},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/00034894211008063"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1177\/01945998221074528"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/0145561320919656"},{"key":"e_1_2_7_16_1","unstructured":"U.S. Food and Drug Administration MAUDE\u2010Manufacturer and User Facility Device Experience accessed December 11 2024 https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfmaude\/search.cfm."},{"key":"e_1_2_7_17_1","unstructured":"U.S. National Library of Medicine A Study of the Safety and Efficacy of the Tympanostomy Tube Delivery System (TTDS) in Patients Requiring Tympanostomy Tubes (ClinicalTrials.gov Identifier: NCT01202578). ClinicalTrials.gov 2010retrieved December 18 2024 from https:\/\/clinicaltrials.gov\/study\/NCT01202578?term=NCT01202578&rank=1."},{"key":"e_1_2_7_18_1","volume-title":"Oxford Centre for Evidence\u2010Based Medicine: Levels of Evidence","author":"Howick J.","year":"2009"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.28612"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1177\/0194599817707178"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1177\/01455613231212829"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/lio2.533"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijporl.2020.110221"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijporl.2015.11.003"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/ohn.336"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.29040"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1067\/mhn.2001.113941"}],"container-title":["The Laryngoscope"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lary.32434","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T09:07:59Z","timestamp":1765876079000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/lary.32434"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7,17]]},"references-count":26,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["10.1002\/lary.32434"],"URL":"https:\/\/doi.org\/10.1002\/lary.32434","archive":["Portico"],"relation":{},"ISSN":["0023-852X","1531-4995"],"issn-type":[{"value":"0023-852X","type":"print"},{"value":"1531-4995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,7,17]]},"assertion":[{"value":"2025-01-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-07-09","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-07-17","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}